Head of Regulatory Affairs

Introduction

A mid-size, well established Medical Device company based in Germany is searching for a talented, experienced Head of Regulatory Affairs. This organisation boasts a wide range of Class I – II OTC Medical Device products treating conditions such as colds, eczema, dry eyes, allergies and more.

This role will offer you

• The opportunity to stable, long-running family business

• Opportunity for growth in your career with role progression and education

• Opportunity to work with a broad product portfolio

You will be responsible for

• Reporting to C-Suite Leadership Global Regulatory Strategy Ideas

• Oversee and Implement Global Regulatory Submissions (EU, Middle East, US)

• Technical File Creation and Review

• Vigilance Reporting

• Working Cross-Functionally with Product Development and Marketing from Regulatory Affairs Perspective

You will bring the following

• Extensive Experience in Regulatory Affairs in Medical Devices / OTC Products

• Global Regulations Knowledge (EMEA / US)

• Experience in Smaller Organisations with Flat Hierarchical Structures

• Experience as Point of Contact for Notified Body

BioTalent Ltd are acting as an employment agency in relation to this opportunity.